REVEAL: Reduction of Infarct Expansion and Ventricular Remodeling With Erythropoietin After Large Myocardial Infarction
2017年5月8日 更新者：National Institute on Aging (NIA)
Effects of Erythropoietin on Infarct Size and Left Ventricular Remodeling in Survivors of Large Myocardial Infarctions
The purpose of this study is to evaluate whether erythropoietin can help limit the damage to the heart in patients with acute heart attacks.
研究概览
详细说明
REVEAL is a randomized, double-blinded, placebo-controlled, parallel phase II clinical study that will evaluate the effects of erythropoietin administration on infarct size, left ventricular remodeling and circulating endothelial progenitor cells in patients with large myocardial infarctions (MI).
The study will be conducted in two phases: a dose-escalation safety phase and a single dose efficacy phase.
Eligible patients who present to the hospital with an acute ST-elevation MI and who agree to participate in this study will be randomly assigned to receive a single infusion of study medication consisting either of erythropoietin or placebo.
The size of the infarction and the dimensions of the heart will be assessed by cardiac magnetic resonance imaging (MRI) within 2-6 days of the infusion of the study medication, and again approximately 3 months later.
研究类型
介入性
注册 (实际的)
223
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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District of Columbia
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Washington, D.C.、District of Columbia、美国、20010
- Washington Hospital Center
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Florida
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Miami、Florida、美国、33136
- University of Miami, School of Medicine
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Georgia
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Atlanta、Georgia、美国、30322
- Emory University Hospital
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Michigan
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Detroit、Michigan、美国、48202
- Henry Ford Hospital
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Royal Oak、Michigan、美国、48073-6769
- William Beaumont Hospital
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Minnesota
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Rochester、Minnesota、美国、55905
- Mayo Clinic, Rochester
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New York
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Brooklyn、New York、美国、11215
- New York Methodist Hospital
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New York、New York、美国、10021-4872
- Cornell University
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New York、New York、美国、10021
- NY Presbyterian Hospital
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New York、New York、美国、10021
- Weill Medical College
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North Carolina
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Durham、North Carolina、美国、27710
- Duke University
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Winston-Salem、North Carolina、美国、27103
- Wake Forest University
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Ohio
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Columbus、Ohio、美国、43210
- Ohio State University Medical Center
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Pennsylvania
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Hershey、Pennsylvania、美国、17033
- Penn State Heart and Vascular Institute
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Tennessee
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Brentwood、Tennessee、美国、37027
- Nashville Cardiovascular Magnetic Resonance Institute
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Virginia
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Richmond、Virginia、美国、23298
- Virginia Commonwealth University Medical Center
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
21年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
- INCLUSION CRITERIA:
Age greater than 21 years
Acute ST-elevation myocardial infarction
Referral for primary or rescue angioplasty
Revascularization procedure within 8 hours from the onset of ischemic symptoms
TIMI (Thrombolysis in myocardial infarction) flow grade 0 or 1 in the culprit coronary artery at the beginning of coronary angiography
Successful revascularization of infarct-related artery
EXCLUSION CRITERIA:
Clinical indication for erythropoietin
STEMI (ST-elevation myocardial infarction) due to occlusion of a branch vessel
Any history of prior MI, PCI (Percutaneous coronary intervention), CABG (Coronary artery bypass graft), cardiomyopathy, myocarditis, or CHF (congestive heart failure)
Hypersensitivity to human albumin, mammalian cell-derived products, or erythropoietin
Hematocrit greater than 42% in men or greater than 40% in women at the time of study drug administration
Uncontrolled hypertension at the time of study drug administration
Cardiogenic shock
Need for coronary surgical revascularization as determined at the time of the index coronary catheterization
History of hypercoagulable disorder, thromboembolic event, or venous thrombosis
History of stroke or TIA (transient ischemic attack)
History of seizures
Contraindication to MRI
Pregnancy or nursing mother
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
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安慰剂比较：Dose Escalation Safety
The objective of the first phase is to evaluate the safety of escalating doses of Epoetin alfa in patients with STEMIs.
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Randomized
其他名称：
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安慰剂比较：Single Dose Efficacy
Single parenteral administration of 60000 U of epoetin alfa.
The objectives of the second phase are to investigate the effects of the highest safe dose on infarct size, left ventricular remodeling and endothelial progenitor cells.
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Randomized
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Infarct Size in the Territory of the Infarct Related Artery
大体时间：performed 2 to 6 days after study medication administration (first CMR)
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Infarct size, expressed as percentage of LV mass, assessed by cardiac magnetic resonance (CMR) imaging.
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performed 2 to 6 days after study medication administration (first CMR)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Infarct Size in the Territory of the Infarct Related Artery
大体时间：12 ± 2 weeks after study medication
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Infarct size, expressed as percentage of LV mass, assessed by cardiac magnetic resonance (CMR) imaging.
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12 ± 2 weeks after study medication
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LV Ejection Fraction
大体时间：2 to 6 days after study medication administration (first CMR) and 12 ± 2 weeks later (second CMR)
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2 to 6 days after study medication administration (first CMR) and 12 ± 2 weeks later (second CMR)
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LV Volume Indexed to BSA
大体时间：2 to 6 days after study medication administration (first CMR) and 12 ± 2 weeks later (second CMR)
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2 to 6 days after study medication administration (first CMR) and 12 ± 2 weeks later (second CMR)
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LV Mass Indexed to BSA
大体时间：2 to 6 days after study medication administration (first CMR) and 12 ± 2 weeks later (second CMR)
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2 to 6 days after study medication administration (first CMR) and 12 ± 2 weeks later (second CMR)
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Vital Signs
大体时间：baseline, 24 hours, 48 hours, 14 (+/- 5) days, and 30 (+/- 5) days
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baseline, 24 hours, 48 hours, 14 (+/- 5) days, and 30 (+/- 5) days
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Hemoglobin Levels
大体时间：baseline, 24 hours, 48 hours, 14 (+/- 5) days, and 30 (+/- 5) days
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baseline, 24 hours, 48 hours, 14 (+/- 5) days, and 30 (+/- 5) days
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Reticulocyte Counts
大体时间：baseline, 24 hours, 48 hours, 14 (+/- 5) days, and 30 (+/- 5) days
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baseline, 24 hours, 48 hours, 14 (+/- 5) days, and 30 (+/- 5) days
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Number of Participants With Clinical Events
大体时间：from randomization to second CMR
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from randomization to second CMR
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Edward G Lakatta, M.D.、National Institute on Aging (NIA)
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Bogoyevitch MA. An update on the cardiac effects of erythropoietin cardioprotection by erythropoietin and the lessons learnt from studies in neuroprotection. Cardiovasc Res. 2004 Aug 1;63(2):208-16. doi: 10.1016/j.cardiores.2004.03.017.
- Parsa CJ, Matsumoto A, Kim J, Riel RU, Pascal LS, Walton GB, Thompson RB, Petrofski JA, Annex BH, Stamler JS, Koch WJ. A novel protective effect of erythropoietin in the infarcted heart. J Clin Invest. 2003 Oct;112(7):999-1007. doi: 10.1172/JCI18200.
- Maiese K, Li F, Chong ZZ. New avenues of exploration for erythropoietin. JAMA. 2005 Jan 5;293(1):90-5. doi: 10.1001/jama.293.1.90.
- Povsic TJ, Najjar SS, Prather K, Zhou J, Adams SD, Zavodni KL, Kelly F, Melton LG, Hasselblad V, Heitner JF, Raman SV, Barsness GW, Patel MR, Kim RJ, Lakatta EG, Harrington RA, Rao SV. EPC mobilization after erythropoietin treatment in acute ST-elevation myocardial infarction: the REVEAL EPC substudy. J Thromb Thrombolysis. 2013 Nov;36(4):375-83. doi: 10.1007/s11239-013-0944-6.
- Najjar SS, Rao SV, Melloni C, Raman SV, Povsic TJ, Melton L, Barsness GW, Prather K, Heitner JF, Kilaru R, Gruberg L, Hasselblad V, Greenbaum AB, Patel M, Kim RJ, Talan M, Ferrucci L, Longo DL, Lakatta EG, Harrington RA; REVEAL Investigators. Intravenous erythropoietin in patients with ST-segment elevation myocardial infarction: REVEAL: a randomized controlled trial. JAMA. 2011 May 11;305(18):1863-72. doi: 10.1001/jama.2011.592.
- Melloni C, Rao SV, Povsic TJ, Melton L, Kim RJ, Kilaru R, Patel MR, Talan M, Ferrucci L, Longo DL, Lakatta EG, Najjar SS, Harrington RA. Design and rationale of the Reduction of Infarct Expansion and Ventricular Remodeling with Erythropoietin after Large Myocardial Infarction (REVEAL) trial. Am Heart J. 2010 Nov;160(5):795-803.e2. doi: 10.1016/j.ahj.2010.09.007.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2005年9月1日
初级完成 (实际的)
2009年7月1日
研究完成 (实际的)
2011年1月1日
研究注册日期
首次提交
2006年9月18日
首先提交符合 QC 标准的
2006年9月18日
首次发布 (估计)
2006年9月20日
研究记录更新
最后更新发布 (实际的)
2017年5月9日
上次提交的符合 QC 标准的更新
2017年5月8日
最后验证
2017年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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